Abstract
A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin and Fenofibrate in bulk and pharmaceutical dosage forms. The determination was performed by using Waters Symmetry C18 (250×4.6mm×5µ) as column stationary phase and Methanol: Acetonitrile: Water in the ratio of (70:10:20 %v/v) as mobile phase. The flow rate of mobile phase was optimized as 1mL/min and effluents were monitored at 274 nm. The retention time of atorvastatin and Fenofibrate were found as 4.15 min and 8.10 min respectively. The method shows linearity concentration ranges between 4-30 μg/mL and 80-400 μg/mL respectively. The developed method was validated for specificity, precision, linearity, accuracy, robustness, Ruggedness, LOD and LOQ. Recovery of atorvastatin and Fenofibrate in formulations was found to be 100.52% and 99.92% respectively which conforms the non-interferences of the excipients in the formulation. the proposed RP- HPLC method can be used for the simultaneous determination of these two drugs in bulk and formulation.
Highlights
Atorvastatin calcium 1-4 (AT) is (β R, δ R)-2-(4fluorophenyl)-β, δ-dihydroxy-5-(1-methyl ethyl)-3phenyl-4-((phenyl amino) carbonyl)-1H-pyrrole-1hepatonoic acid, a HMG CoA reductase inhibitor
The mobile phase conditions were optimized so that the components were not interfered from the solvent and excipients
Several buffer systems at different pH values were trailed in various ratios with methanol, and acetonitrile as mobile phase
Summary
Atorvastatin calcium 1-4 (AT) is (β R, δ R)-2-(4fluorophenyl)-β, δ-dihydroxy-5-(1-methyl ethyl)-3phenyl-4-((phenyl amino) carbonyl)-1H-pyrrole-1hepatonoic acid, a HMG CoA reductase inhibitor. Fenofibrate (FB) is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoic acid, 1-methylethyl ester, it is a lipid lowering agent. (Bhinge, Malipatil, 2012) Literature survey reveals that, few HPLC and HPTLC methods have been reported for simultaneous estimation of ATR and FB as well as in combination with other drugs [1]. Has reported HPLC method for simultaneous estimation of ATR and FB using MethanolAcetonitrile: Phosphate Buffer pH 5.0 (45:25:30 V/V) as eluting solvent. The methods reported by Kadav [2] were excluding the internal standard, which was found to be the limitation of the method. Literature survey revealed number of UV-VIS spectroscopic [3]. NP-HPLC, RPHPLC [4] GC and some electro-analytical methods for estimation of these drug alone or in combination with other drugs [5-17]
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